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Atzumi™ (dihydroergotamine(DHE)) nasal powder is the first and only DHE nasal powder for the acute treatment of migraine with or without aura in adults in an easy-to-use, easy-to-carry device. Atzumi is the first and only product utilizing the SMART (Simple MucoAdhesive Release Technology) platform which combines a proprietary advanced powder and device technology to simplify delivery of DHE. In clinical studies, Atzumi administration provided rapid and sustained DHE concentrations with low variability. DURHAM, N.C., April 30, 2025 /PRNewswire/ -- Satsuma Pharmaceuticals, Inc., a late-stage biopharmaceutical company dedicated to bringing novel treatments to people who suffer from migraine and other debilitating conditions, and its corporate parent, Shin Nippon Biomedical Laboratories, Ltd. (TSE:2395), today announced that the U.S. Food and Drug Administration (FDA) has approved a 505(b)(2) New Drug Application (NDA) for Atzumi™(dihydroergotamine (DHE)) nasal powder for the acute treatment of migraine with or without aura in adults. Atzumi was previously known as STS101. Migraine is a neurological disorder that is thought to be the result of temporary changes in the chemicals, nerves and blood vessels in the brain, with symptoms that are often incapacitating. According to the American Migraine Foundation, approximately 40 million Americans live with migraine. It is the second leading cause of disability worldwide in terms of time lost to disability and most common cause of disability among young women. "The approval of Atzumi is a milestone to celebrate, providing a new option for the acute treatment of migraine combining long-proven benefits of DHE with a patient-friendly and easy-to-use delivery system developed based on SNBL's novel intranasal drug delivery platform technology," said Dr. Ryoichi Nagata, President and CEO of Satsuma. "We believe that Atzumi will contribute to improving the quality of life of patients struggling for relief from these highly disabling problems." "DHE plays a unique clinical role in the acute treatment of migraine, providing patients long lasting effects and the unique ability to provide benefit even when taken late in a migraine attack. The convenience of Atzumi, the only DHE nasal powder, will offer patients ease of use combined with the important known DHE clinical advantages", said Dr. Stewart J. Tepper, M.D., Vice President of the New England Institute for Neurology and Headache in Stamford, Connecticut. About Atzumi Atzumi is a proprietary drug device product incorporating both Satsuma's advanced nasal powder formulation of dihydroergotamine (DHE) administered via its unique nasal delivery device. The product is designed to provide patients an easy-to-use and easy-to-carry treatment option. The FDA approval for Atzumi is based on two clinical studies (Phase 1 PK trial and ASCEND Phase 3 open-label, long-term safety trial), which demonstrated fast absorption, rapid achievement of high DHE plasma concentrations, and sustained DHE plasma levels over time as well as safety and tolerability in subjects with migraine. About Dihydroergotamine (DHE) Since its approval in 1946, DHE has long been recommended in published migraine treatment guidelines as a first-line acute treatment option for migraine and has significant advantages versus other anti-migraine treatments for many patients. However, disadvantages of current DHE liquid nasal spray and injectable products, including invasive and burdensome administration and/or sub-optimal clinical performance, have limited the widespread use of DHE. IMPORTANT SAFETY INFORMATION WARNING: PERIPHERAL ISCHEMIA FOLLOWING COADMINISTRATION WITH STRONG CYP3A4 INHIBITORS Serious and/or life-threatening peripheral ischemia has been associated with the coadministration of dihydroergotamine with strong CYP3A4 inhibitors. Because CYP3A4 inhibition elevates the serum levels of dihydroergotamine, the risk for vasospasm leading to cerebral ischemia and/or ischemia of the extremities is increased. Hence, concomitant use of Atzumi with strong CYP3A4 inhibitors is contraindicated. Indication Atzumi is an ergotamine derivative indicated for the acute treatment of migraine with or without aura in adults. Limitations of Use Atzumi is not indicated for the preventive treatment of migraine or for the management of hemiplegic migraine or migraine with brainstem aura. Contraindications Atzumi is not recommended in patients with: Concomitant use of strong CYP3A4 inhibitors Ischemic heart disease or coronary artery vasospasm Uncontrolled hypertension, peripheral arterial diseases, sepsis, following vascular surgery, or severe hepatic or renal impairment Hypersensitivity to ergot alkaloids Concomitant use of other 5-HT₁ agonists or ergotamine-containing or ergot-type medication within 24 hours Concomitant use of peripheral and central vasoconstrictors Warnings and Precautions Atzumi may cause: Cardiac events: Cardiac events in patients with risk factors of coronary artery diseases: Consider administration of the first dose of Atzumi under medical supervision (including the use of an electrocardiogram) Cerebrovascular events: Cerebrovascular events (eg, cerebral hemorrhage, subarachnoid hemorrhage, and stroke) have been reported, particularly with dihydroergotamine mesylate injection Vasospasm/elevated blood pressure: Dihydroergotamine may cause vasospasm or elevation in blood pressure Medication overuse headache: Detoxification may be necessary Preterm labor: Advise pregnant women of the risk Fibrotic complications: Rare cases have been reported following prolonged daily use of dihydroergotamine mesylate. Administration of Atzumi should not exceed the dosing guidelines or be used for chronic daily administration Local irritation: Local irritation has been reported following administration of Atzumi Most Common Adverse Reactions Most common adverse reactions (incidence >1%) were rhinitis, nausea, altered sense of taste, application site reaction, dizziness, vomiting, somnolence, pharyngitis, and diarrhea. Use in Special Populations Pregnancy: Available data from published literature indicate an increased risk of preterm delivery with Atzumi us during pregnancy. Lactation: Patients should not breastfeed during treatment with Atzumi and for 3 days after the last dose. Please see the Atzumi Full Prescribing Information, including Boxed Warning and Medication Guide. The risk information provided here is not comprehensive. The FDA-approved product labeling can be found at . You can also call 1-888-273-2480 for additional information. About Satsuma Pharmaceuticals Satsuma Pharmaceuticals Inc., a wholly-owned subsidiary of Shin Nippon Biomedical Laboratories, Ltd. (SNBL), is a late-stage biopharmaceutical company headquartered in Research Triangle Park, North Carolina. Since its inception in 2016, Satsuma has focused on combining great science, cutting-edge technology and proven drug therapies to create improved therapeutic products that address the significant unmet needs of patients. Satsuma's team has extensive experience successfully developing, manufacturing and commercializing pharmaceutical products within both large and small companies, and we have particular expertise in the area of drug-device combination products delivered via inhalation. For further information, please visit . About SNBL Shin Nippon Biomedical Laboratories, Ltd. ("SNBL") (TSE:2395) is a listed nonclinical contract research organization (CRO) that was founded in Kagoshima, Japan, in 1957. Based on its corporate philosophy of "Committed to the environment, life, and people", and with a proven track record of accomplishment as the oldest and most established Japanese nonclinical CRO, SNBL is proud to offer a comprehensive portfolio of services and solutions for drug discovery and development for pharmaceutical companies, biotech ventures, universities, and research institutions both in Japan and overseas. The SNBL's Translational Research business engages in drug discovery, with the focus on business development and out-licensing of its proprietary intranasal drug delivery technologies and intranasal devices. For further information, please visit . Cautionary Note on Forward-Looking Statements This press release and any materials distributed in connection with this press release may contain forward-looking statements, beliefs or opinions regarding Satsuma's future business, future position and results of operations, including estimates, forecasts, targets and plans for Satsuma. Without limitation, forward-looking statements often include words such as "targets", "plans", "believes", "hopes", "continues", "expects", "aims", "intends", "ensures", "will", "may", "should", "would", "could" "anticipates", "estimates", "projects" or similar expressions or the negative thereof. These forward-looking statements are based on assumptions about many important factors, including the following, which could cause actual results to differ materially from those expressed or implied by the forward-looking statements: the economic circumstances surrounding SNBL's business, including uncertainty of commercial success for new and existing products; claims or concerns regarding the safety or efficacy of product candidates; general economic conditions in Japan and the United States; competitive pressures and developments; changes to applicable laws and regulations; challenges inherent in new product development, including uncertainty of clinical success and decisions of regulatory authorities and the timing thereof; fluctuations in interest and currency exchange rates; the impact of health crises such as the coronavirus pandemic on Satsuma and its clients and suppliers, including foreign governments in countries in which Satsuma operates, or on other facets of its business; the timing and impact of post-merger integration efforts with acquired companies; the ability to divest assets that are not core to Satsuma's operations and the timing of any such divestment(s); and other factors identified in SNBL's most recent securities report ("Yuka Shoken Houkokusho") and SNBL's other reports filed with the Financial Services Agency, available on SNBL's website at: or at . SNBL does not undertake to update any of the forward-looking statements contained in this press release or any other forward-looking statements it may make, except as required by law or related stock exchange rule. Past performance is not an indicator of future results and the results or statements of SNBL in this press release may not be indicative of, and are not an estimate, forecast, guarantee or projection of SNBL's future results. Medical Information This press release contains information about product candidates that may not be available in all countries, or may be available under different trademarks, for different indications, in different dosages, or in different strengths. Nothing contained herein should be considered a solicitation, promotion or advertisement for any prescription drugs including the ones under development. Inquiries: Satsuma Pharmaceuticals, Inc. E-mail: [email protected] Website: SOURCE Satsuma Pharmaceuticals, Inc. 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Abstracts include a presidential plenary-selected Phase 2 study evaluating the combination of obeticholic acid and bezafibrate in PBC, along with 10 other abstractsMORRISTOWN, N.J., April 30, 2025 (GLOBE NEWSWIRE) -- Intercept Pharmaceuticals, Inc. (Intercept), part of the Alfasigma Group, today announced 11 submitted abstracts have been accepted for presentation at Digestive Disease Week 2025, including oral presentations of data from a Phase 2 study evaluating the combination of obeticholic acid and bezafibrate in PBC, and investigational data for INT-787, a next-generation FXR agonist. The conference will be held from May 3-6 in San Diego. The abstracts showcase the Company’s breadth of research in the gastrointestinal (GI) and hepatology therapeutic areas. The data encompass multiple areas of high unmet need, including primary biliary cholangitis (PBC); primary sclerosing cholangitis (PSC); severe alcohol-associated hepatitis (sAH), a liver disease increasing in prevalence, especially among women; and chronic intestinal pseudo-obstruction (CIPO), a rare condition characterized by severe impairment of intestinal activity. “We look forward to sharing details of our clinical-development program progress with the scientific community, including our ongoing Phase 2 study of a potential first-in-class treatment for severe alcohol-associated hepatitis,” said Sangeeta Sawhney, M.D., Senior Vice President, Global Head, GI Therapeutic Area, Alfasigma. “We're also going to share the first six-year data for a second-line therapy for PBC, which gives insights into long-term safety and effectiveness." Presentations by Intercept and Alfasigma at DDW 2025: Oral Presentations “COMBINED EFFECT OF OBETICHOLIC ACID AND BEZAFIBRATE IN PATIENTS WITH PRIMARY BILIARY CHOLANGITIS AND INADEQUATE RESPONSE OR INTOLERANCE TO URSODEOXYCHOLIC ACID: 6-MONTH RESULTS FROM A PHASE 2 TRIAL” (Presentation #4)Session: AASLD Presidential PlenarySaturday, May 3, 9:15 AM ETChristophe Corpechot, Vaclav Hejda, Heng Zou, Antonio Civitarese, Alejandra Villamil, Frederik Nevens “FXR AGONIST INT-787 INHIBITS INFLAMMATION, FIBROSIS, SENESCENCE, AND APOPTOSIS ARREST IN HUMAN CHOLANGIOCYTES MODELING PSC” (Presentation #879)Session: Cutting-Edge Insights into PSC: From Mechanisms to TherapiesMonday, May 5, 4:45 PM ETFrancesca De Franco, Daniela Passeri, Sanjay Kansra, Luciano Adorini, Mary Erickson, Roberto Pellicciari Poster Presentations “OBETICHOLIC ACID NORMALIZES INFLAMMATORY BIOMARKERS IN PATIENTS WITH PRIMARY BILIARY CHOLANGITIS” (Poster #Sa1500)Session: Liver Inflammation and ImmunobiologySaturday, May 3, 12:30 PM ETDavid E. Jones, Christopher L. Bowlus, Arash Thranian, Mary Erickson, Jing Li, Christopher Gasink, Robert G. Gish “US POPULATION–BASED EPIDEMIOLOGY OF PRIMARY BILIARY CHOLANGITIS: EXAMINATION OF PATIENT CHARACTERISTICS AND INCIDENCE OF HEPATIC OUTCOMES IN A US HEALTHCARE CLAIMS DATABASE” (Poster #Su1675)Session: Health Disparities in Patients with Liver DiseaseSunday, May 4, 12:30 PM ETAparna Goel, Bridget L. Balkaran, Chris White, Radhika Nair, Anne Chiplin, Jing Li, Jayashri Desai, Joanna P. MacEwan “REAL-WORLD ADHERENCE TO OBETICHOLIC ACID THERAPY FOR PRIMARY BILIARY CHOLANGITIS” (Poster #Mo1626)Session: Human and Experimental Cholestatic and Autoimmune Liver DiseasesMonday, May 5, 12:30 PM ETRobert G. Gish, Joanna P. MacEwan, Jennifer Hernandez, Radhika Nair, Jing Li, Darren Wheeler, Anh Singhania, Leona Bessonova “PATIENTS WITHOUT BASELINE PRURITUS WHO INITIATE TREATMENT WITH OCA HAVE SIMILAR RISK OF DEVELOPING TREATMENT-EMERGENT PRURITUS AS THOSE WHO ARE NOT ON TREATMENT WITH OCA” (Poster #Mo1618)Session: Human and Experimental Cholestatic and Autoimmune Liver DiseasesMonday, May 5, 12:30 PM ETDavid Jones, Aparna Goel, Ann Moore, Jing Li, Darren Wheeler, Christopher White, and David W. Victor III “STABILIZATION OF ENHANCED LIVER FIBROSIS AND LIVER STIFFNESS MEASURES IN THE OPEN-LABEL EXTENSION OF THE PHASE 3 POISE TRIAL OF OBETICHOLIC ACID FOR THE TREATMENT OF PRIMARY BILIARY CHOLANGITIS” (Poster #Mo1667)Session: Non-Invasive Assessment of Liver DiseaseMonday, May 5, 12:30 PM ET Robert G. Gish, Darren Wheeler, Jing Li, Christopher Gasink, Alan Bonder “FARNESOID X RECEPTOR AGONIST INT-787 PROTECTS HUMAN LIVER ORGANOIDS FROM ALCOHOL-INDUCED INJURY” (Poster #Su1618)Session: Alcoholic-associated Liver Disease Including Alcohol-associated HepatitisSunday, May 4, 12:30 PM ETFrancesca De Franco, Daniela Passeri, Sanjay Kansra, Luciano Adorini, Mary Erickson, Roberto Pellicciari “FARNESOID X RECEPTOR AGONIST INT-787 EXHIBITS HIGH INTESTINAL LOCALIZATION” (Poster #Su1635)Session: Alcoholic-associated Liver Disease Including Alcohol-associated HepatitisSunday, May 4, 12:30 PM ETJennifer Burkey, Sanjay Kansra, Antonio Macchiarulo, Kenneth Brouwer, Luciano Adorini, Mary Erickson, Roberto Pellicciari “PHARMACOKINETIC AND PHARMACODYNAMIC INTERACTION OF OBETICHOLIC ACID AND BEZAFIBRATE IN HEALTHY VOLUNTEERS” (Poster #Mo1628)Session: Human and Experimental Cholestatic and Autoimmune Liver DiseasesMonday, May 5, 12:30 PM ETJennifer Burkey, Karen Brown, Heng Zou, Jennifer Boston, Mary Erickson “DEVELOPMENT OF A DE NOVO CLINICAL OUTCOME ASSESSMENT FOR CHRONIC INTESTINAL PSEUDO-OBSTRUCTION" (Poster #Mo1258)Session: Patient Report and Clinical Outcomes: IBD, GERC, Functional Disorders, Other Monday, May 5, 12:30 PM ETMadhusudan Grover, Jan Tack, Sara Manzoni, Elena Pasquali, Valeria Scuderi, Vincenzo Stanghellini More information about these presentations will be made available after the respective embargoes, as set by the DDW organizers, are lifted for each presentation. A full list of sessions at DDW 2025 is available at www.ddw.org. Attendees of DDW can visit Intercept at booths #2011 and #2411 throughout the meeting. About Digestive Disease WeekDigestive Disease Week (DDW) is the largest international gathering of physicians, researchers and academics in the fields of gastroenterology, hepatology, endoscopy and gastrointestinal surgery. Jointly sponsored by the American Association for the Study of Liver Diseases (AASLD), the American Gastroenterological Association (AGA), the American Society for Gastrointestinal Endoscopy (ASGE) and the Society for Surgery of the Alimentary Tract (SSAT), DDW is an in-person and online meeting from May 3-6, 2025. The meeting showcases more than 5,600 abstracts and hundreds of lectures on the latest advances in GI research, medicine and technology. More information can be found at www.ddw.org. About Primary Biliary CholangitisPrimary biliary cholangitis (PBC) is a rare, progressive and chronic autoimmune disease that affects the bile ducts in the liver and is most prevalent (approximately 1 in 10,000) in women over the age of 40. PBC causes bile acid to build up in the liver, resulting in inflammation and scarring (fibrosis), which, if left untreated, can lead to cirrhosis, a liver transplant or death. About Severe Alcohol-Associated Hepatitis (sAH)Alcohol-related liver disease (ALD) as a cause of chronic liver disease is on the rise in the U.S. and is currently the leading indication for liver transplant listing overall in the U.S. Patients with severe alcohol-associated hepatitis (sAH) are now younger, with an increased representation of females compared to past decades, reflecting changing patterns of alcohol consumption in the U.S. Currently, there are no medicines with an approved indication to treat patients with sAH. About Primary Sclerosing CholangitisPrimary sclerosing cholangitis (PSC) is a rare, life-threatening, chronic cholestatic liver disease characterized by progressive destruction of bile ducts that leads to the development of cirrhosis and end-stage liver disease or cancer in a majority of patients. About the Investigational Obeticholic Acid-Bezafibrate CombinationIntercept has two ongoing Phase 2 studies (747-213 / NCT04594694, 747-214 / NCT05239468) that are exploring a range of therapeutic doses for the combination of obeticholic acid (OCA) and bezafibrate for the potential treatment of individuals with PBC. Obeticholic acid, a farnesoid X receptor (FXR) agonist, is marketed by Intercept as OCALIVA in the United States for the treatment of PBC (see below for full indication and Important Safety Information). Bezafibrate, a pan-peroxisome proliferator-activated receptor (pan-PPAR) agonist, is not approved in the United States for any indication. FXR and PPAR are distinct pathways that each play a role in PBC. Simultaneously targeting both pathways may offer the greatest potential to impact bile acid synthesis, metabolism, and clearance that underly cholestatic liver diseases. Published studies establish a clinical proof-of-concept which suggests that the combination of obeticholic acid and bezafibrate may provide additive clinical efficacy and tolerability benefits in the treatment of PBC. Obeticholic acid-bezafibrate combination therapy is investigational; safety and efficacy have not been established. About OCALIVA (obeticholic acid)OCALIVA, a farnesoid X receptor (FXR) agonist, is indicated for the treatment of adult patients with primary biliary cholangitis (PBC) without cirrhosis orwith compensated cirrhosis who do not have evidence of portal hypertension, either in combination with ursodeoxycholic acid (UDCA) with an inadequate response to UDCA or as monotherapy in patients unable to tolerate UDCA. This indication is approved under accelerated approval based on a reduction in alkaline phosphatase (ALP). An improvement in survival or disease-related symptoms has not been established. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials. IMPORTANT SAFETY INFORMATION WARNING: HEPATIC DECOMPENSATION AND FAILURE IN PRIMARY BILIARY CHOLANGITIS PATIENTS WITH CIRRHOSIS Hepatic decompensation and failure, sometimes fatal or resulting in liver transplant, have been reported with OCALIVA treatment in primary biliary cholangitis (PBC) patients with either compensated or decompensated cirrhosis. OCALIVA is contraindicated in PBC patients with decompensated cirrhosis, a prior decompensation event, or with compensated cirrhosis who have evidence of portal hypertension. Permanently discontinue OCALIVA in patients who develop laboratory or clinical evidence of hepatic decompensation; have compensated cirrhosis and develop evidence of portal hypertension, or experience clinically significant hepatic adverse reactions while on treatment. Contraindications OCALIVA is contraindicated in patients with: decompensated cirrhosis (e.g., Child-Pugh Class B or C) or a prior decompensation eventcompensated cirrhosis who have evidence of portal hypertension (e.g., ascites, gastroesophageal varices, persistent thrombocytopenia)complete biliary obstruction Warnings and Precautions Hepatic Decompensation and Failure in PBC Patients with Cirrhosis Hepatic decompensation and failure, sometimes fatal or resulting in liver transplant, have been reported with OCALIVA treatment in PBC patients with cirrhosis, either compensated or decompensated. Among post-marketing cases reporting it, median time to hepatic decompensation (e.g., new onset ascites) was four months for patients with compensated cirrhosis; median time to a new decompensation event (e.g., hepatic encephalopathy) was 2.5 months for patients with decompensated cirrhosis. Some of these cases occurred in patients with decompensated cirrhosis when they were treated with higher than the recommended dosage for that patient population; however, cases of hepatic decompensation and failure have continued to be reported in patients with decompensated cirrhosis even when they received the recommended dosage. Hepatotoxicity was observed in the OCALIVA clinical trials. A dose-response relationship was observed for the occurrence of hepatic adverse reactions including jaundice, worsening ascites, and primary biliary cholangitis flare with dosages of OCALIVA of 10 mg once daily to 50 mg once daily (up to 5-times the highest recommended dosage), as early as one month after starting treatment with OCALIVA in two 3-month, placebo-controlled clinical trials in patients with primarily early stage PBC. Routinely monitor patients for progression of PBC, including hepatic adverse reactions, with laboratory and clinical assessments to determine whether drug discontinuation is needed. Closely monitor patients with compensated cirrhosis, concomitant hepatic disease (e.g., autoimmune hepatitis, alcoholic liver disease), and/or with severe intercurrent illness for new evidence of portal hypertension (e.g., ascites, gastroesophageal varices, persistent thrombocytopenia), or increases above the upper limit of normal in total bilirubin, direct bilirubin, or prothrombin time to determine whether drug discontinuation is needed. Permanently discontinue OCALIVA in patients who develop laboratory or clinical evidence of hepatic decompensation (e.g., ascites, jaundice, variceal bleeding, hepatic encephalopathy), have compensated cirrhosis and develop evidence of portal hypertension (e.g., ascites, gastroesophageal varices, persistent thrombocytopenia), experience clinically significant hepatic adverse reactions, or develop complete biliary obstruction. If severe intercurrent illness occurs, interrupt treatment with OCALIVA and monitor the patient’s liver function. After resolution of the intercurrent illness, consider the potential risks and benefits of restarting OCALIVA treatment. Severe Pruritus Severe pruritus was reported in 23% of patients in the OCALIVA 10 mg arm, 19% of patients in the OCALIVA titration arm, and 7% of patients in the placebo arm in a 12-month double-blind randomized controlled clinical trial of 216 patients. Severe pruritus was defined as intense or widespread itching, interfering with activities of daily living, or causing severe sleep disturbance, or intolerable discomfort, and typically requiring medical interventions. Consider clinical evaluation of patients with new onset or worsening severe pruritus. Management strategies include the addition of bile acid binding resins or antihistamines, OCALIVA dosage reduction, and/or temporary interruption of OCALIVA dosing. Reduction in HDL-C Patients with PBC generally exhibit hyperlipidemia characterized by a significant elevation in total cholesterol primarily due to increased levels of high-density lipoprotein-cholesterol (HDL-C). Dose-dependent reductions from baseline in mean HDL-C levels were observed at 2 weeks in OCALIVA-treated patients, 20% and 9% in the 10 mg and titration arms, respectively, compared to 2% in the placebo arm. Monitor patients for changes in serum lipid levels during treatment. For patients who do not respond to OCALIVA after one year at the highest recommended dosage that can be tolerated (maximum of 10 mg once daily), and who experience a reduction in HDL-C, weigh the potential risks against the benefits of continuing treatment. Adverse Reactions The most common adverse reactions (≥5%) are pruritus, fatigue, abdominal pain and discomfort, rash, oropharyngeal pain, dizziness, constipation, arthralgia, thyroid function abnormality, and eczema. Drug Interactions Bile Acid Binding Resins Bile acid binding resins such as cholestyramine, colestipol, or colesevelam adsorb and reduce bile acid absorption and may reduce the absorption, systemic exposure, and efficacy of OCALIVA. If taking a bile acid binding resin, take OCALIVA at least four hours before or four hours after taking the bile acid binding resin, or at as great an interval as possible.Warfarin The International Normalized Ratio (INR) decreased following coadministration of warfarin and OCALIVA. Monitor INR and adjust the dose of warfarin, as needed, to maintain the target INR range when co-administering OCALIVA and warfarin.CYP1A2 Substrates with Narrow Therapeutic Index Obeticholic acid may increase the exposure to concomitant drugs that are CYP1A2 substrates. Therapeutic monitoring of CYP1A2 substrates with a narrow therapeutic index (e.g., theophylline and tizanidine) is recommended when co-administered with OCALIVA.Inhibitors of Bile Salt Efflux Pump Avoid concomitant use of inhibitors of the bile salt efflux pump (BSEP) such as cyclosporine. Concomitant medications that inhibit canalicular membrane bile acid transporters such as the BSEP may exacerbate accumulation of conjugated bile salts including taurine conjugate of obeticholic acid in the liver and result in clinical symptoms. If concomitant use is deemed necessary, monitor serum transaminases and bilirubin. Please click here for Full Prescribing Information, including boxed WARNING. To report SUSPECTED ADVERSE REACTIONS, contact Intercept Pharmaceuticals, Inc. at 1-844-782-ICPT or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. About InterceptIntercept, part of the Alfasigma Group since 2023, focuses on the development and commercialization of novel therapeutics to treat serious liver and GI diseases, including primary biliary cholangitis (PBC) and severe alcohol-associated hepatitis (sAH). Intercept owns the commercial rights to OCALIVA in the U.S. market. For more information, please visit www.interceptpharma.com or connect with the Company on LinkedIn, and X (formerly Twitter). About Alfasigma Alfasigma is a global pharmaceutical company founded over 75 years ago in Italy, where it is headquartered (in Bologna and Milan). The Group operates in over 100 markets spanning Europe, North and South America, Asia, and Africa. It has offices in many countries, including Italy, the United States (US), Spain, Germany, Mexico, and China; production sites in Italy, Spain, and the US; and R&D labs in Italy (Pomezia and Bergamo). Alfasigma employs approximately 4,000 people dedicated to research, development, production, and distribution of medicinal products contributing to its mission to provide better health and a better quality of life for patients, caregivers, and healthcare providers. It focuses on three main therapeutic areas: Gastroenterology/Hepatology, Vascular, and Rheumatology. Its portfolio spans from primary care to specialty care, rare disease medications, and consumer health products, including medical foods and nutraceuticals. For more information, please visit www.alfasigma.com or connect with the Company on LinkedIn, ContactFor more information about Intercept, please contact: media@interceptpharma.com

Tokyo, Japan and Cambridge, UK, 14 February 2025 – Nxera Pharma Co., Ltd. (“Nxera” or “the Company”; TSE 4565) provides an update on operational activities and reports its consolidated results for the fourth quarter and 12 months ended 31 December 2024. The full report can be viewed here. Chris Cargill, President & CEO of Nxera, commented: “2024 was a transformational year for Nxera during which we made excellent progress under our new company name and brand towards becoming a leading technology driven biopharmaceutical company bringing new medicines to patients in Japan and globally. “We made fantastic commercial progress, with two products – PIVLAZ™ and QUVIVIQ™ (partnered with Shionogi) – recently launched in Japan driving top line revenue growth. We plan to make these products available to patients in South Korea shortly, in addition to other key APAC markets (ex-China). “Furthermore, and importantly, we saw significant advances across our partnered pipeline in 2024, with multiple programs moving towards late-stage clinical development and generating approximately US$90 million in upfront and milestone payments. These programs address some of the fastest growing therapeutic areas of unmet need, including neurology/neuropsychiatry, metabolic diseases and immunology and inflammation. The progress made by partner Neurocrine to advance its muscarinic agonist portfolio during the year has been particularly exciting and will lead to the first Nxera-designed molecule entering Phase 3 trials in 2025. “Our three wholly owned programs are also advancing as planned in early clinical development, with several important milestones expected over the next 12-18 months. Further, the continued investment in our NxWave™ platform, alongside our collaborations with cutting-edge technology companies, is generating exciting new discovery opportunities within the GPCR target universe, and potentially beyond to other important transmembrane target classes, such as ion channels or transporters. In addition, it allows us to explore new modalities against GPCR targets of interest, such as peptides and antibodies, broadening our capabilities and opportunities even more. “Going into 2025, Nxera is well capitalized and very well positioned – with multiple clinical data readouts and other potential catalysts expected during the year – to build on the tremendous work done by our exceptional and dedicated team, as we continue our mission to bring innovative therapies to patients in Japan and around the world.” Operational Highlights for Q4 2024 Significant growth in PIVLAZ® (clazosentan sodium) 150mg sales in Japan during first full year of Nxera ownership Rapidly becoming standard of care in Japan with neurosurgeons for prevention of cerebral vasospasm in patients with aneurysmal subarachnoid haemorrhage (aSAH)Market share increased from 57% in 2023 to 69% in 2024Q4 2024 net sales of JPY 4,282 million, FY 2024 net sales of JPY 12,651 million (US$83.5 million, representing 14% growth vs FY 2023) QUVIVIQ™ (daridorexant) 25 and 50 mg launched in Japan for the treatment of adult patients with insomnia Insomnia affects about 20% of Japanese adults and is recognized as an important national issue impacting both physical and mental health.QUVIVIQ™ is a novel dual orexin receptor agonist that was successfully developed through a Phase 3 trial by Nxera Pharma Japan (“NPJ,” a wholly owned subsidiary of Nxera Pharma).QUVIVIQ™ was launched in December 2024 under a commercial partnership agreement signed in October 2024 with Shionogi, which is solely responsible for distribution and sales of QUVIVIQ™ in Japan. NPJ is responsible in part for provision of drug product. Strategy to expand market for daridorexant underway with start of Phase 3 trial in South Korea Insomnia affects an estimated 15-25% of the adult population in South Korea, or 6.5-11 million people. The randomized, double-blind, placebo-controlled Phase 3 study in adult and elderly subjects with insomnia is expected to run for 12 months with results expected during 1H 2026. Further progress in sleep/wake disorders made by partner Centessa, which initiated a Phase 2 trial of ORX750 ORX750 is an investigational, orally administered, highly potent and selective orexin receptor 2 agonist, designed using Nxera technology to target the underlying pathophysiology of orexin neuron loss in narcolepsy type 1 and other sleep-wake disorders. New multi-target partnership and licensing agreement with UK techbio company Antiverse to design antibodies for validated but challenging GPCR targets The collaboration combines Antiverse’s generative AI antibody design expertise with Nxera’s NxWave™ platform, with Nxera retaining exclusive rights to develop and commercialize any resulting candidates. Experienced Pharma Executive Makoto Sugita, M.D., Ph.D., MBA, Appointed as Chief Medical Officer and President of NPJ Dr. Sugita was formerly Vice President, Head of R&D for Bristol Myers Squibb in Japan – he brings nearly 20 years’ experience in R&D and commercial roles working within the Japanese businesses of global pharmaceutical companies. Nxera Pharma won Biotech Company of the Year and Financing Deal of the Year at the Citeline Japan Awards 2024 Awards recognize outstanding advancements and innovations in the Japanese pharma and biotech sector. Post-period Events Clinical development progress with partnered muscarinic agonist portfolio noted by Neurocrine at 43rd Annual J.P. Morgan Healthcare Conference NBI-1117568 (an oral, muscarinic M4-selective agonist) End of Phase 2 meeting with the US Food & Drug Administration completed and reiteration of plans to begin Phase 3 studies in schizophrenia in 1H 2025.Initiate Phase 2 study in bipolar mania in 2H 2025. NBI-1117570 (a dual M1 / M4 agonist) Initiate Phase 2 study in schizophrenia in 2H 2025. NBI-1117567 (an M1-preferring agonist) and NBI-1117569 (an M4-preferring agonist) Phase 1 trials underway targeting neurological and neuropsychiatric conditions with data readouts anticipated during 2025. Operational Highlights for Full Year 2024 Corporate highlights Nxera Pharma, the new name for Sosei Heptares, came into effect on 1 April 2024 along with the launch of a new corporate brand and identity designed to capture the Group’s ambition to be at the forefront of the next era of biopharmaceuticals and medicineSenior team strengthened with appointments of experienced biopharma executives Toshihiro Maeda as Chief Operating Officer and senior strategy consultant Patrick Branch as Head of Business Development for Japan and APAC Progress with in-house programs Approval of QUVIVIQ™ (daridorexant) 25 and 50 mg by the Ministry of Health, Labour and Welfare of Japan for the treatment of adult patients with insomnia received in September 2024First subject dosed in a Phase 1 trial with NXE0033744, a novel, potent, selective and gut-restricted EP4 receptor agonist in development for the treatment of Inflammatory Bowel Disease (IBD) Full ownership of NXE0027477 regained from GSK – NXE-477 is a clinic-ready, highly selective, first-in-class, oral GPR35 agonist in development as a potential new treatment for IBD. Nxera and PrecisionLife expanded their 2022 strategic R&D partnership into autoimmune disorders with the aim of identifying new drug targets and subsequently potential precision targeted therapies for complex, chronic conditions. Progress with partnered programs Approximately US$70 million in milestone payments received by Nxera based on progress made across multiple partnered programs Neurocrine presented positive Phase 2 data for schizophrenia candidate NBI-‘568 and announced its intention to advance it into Phase 3 trials in 2025, triggering a US$35 million payment to Nxera.Successful completion of long-term preclinical toxicity program with NBI-‘568, supporting its chronic dosing in future clinical trials, triggered a US$15 million payment from Neurocrine First R&D milestone reached under a multi-target discovery collaboration with AbbVie in neurological diseases resulted in a payment of US$10 million to NxeraProgress made by Centessa advancing ORX750 into and through Phase 1 development resulted in a milestone payment to Nxera of US$4.6 million US$2.5 million milestone payment received from Formosa Pharmaceuticals for US approval of APP13007 for the treatment of post-operative inflammation and pain following ocular surgery New global collaboration and exclusive option-to-license agreement signed with Boehringer Ingelheim to develop first-in-class treatments targeting all symptoms of schizophrenia Single-target agreement focused on development of novel, small molecule agonists of GPR52 discovered by Nxera with the potential to simultaneously address positive, negative and cognitive symptoms of schizophreniaNxera received EUR 25 million upfront from Boehringer Ingelheim and is eligible for an option exercise payment of EUR 60 million and further milestone payments totalling up to EUR 670 million plus tiered royalties Financial Highlights for the 12-month Period ended 31 December 2024 Revenue totalled JPY 28,835 million (US$190.4 million*), an increase of JPY 16,069 million (US$99.6 million) vs. the prior year. This increase was primarily due to the inclusion of NPJ in the scope of consolidation from July 2023 resulting in twelve months of PIVLAZ® sales being included in 2024 compared to circa five months in 2023, as well as signing one new R&D partnership agreement and the occurrence of five R&D milestone events in the current year vs. no upfront fees and the occurrence of three R&D milestone events in the prior year. R&D expenses totalled JPY 11,816 million (US$78.0 million), an increase of JPY 1,741 million (US$6.3 million) vs. the prior year. This increase primarily reflects an increased investment in R&D plus the impact of the weaker Yen. JPY 1,483 million (US$9.8 million) has been included for R&D expenses relating to NPJ/NPK.SG&A expenses totalled JPY 16,015 million (US$105.8 million), an increase of JPY 6,050 million (US$34.8 million) vs. the prior corresponding period. This increase was primarily due to an increase in SG&A expenses relating to the NPJ/NPK businesses, including an amortization charge on Idorsia related intangible assets. JPY 8,972 million (US$59.3 million) has been included for SG&A expenses relating to NPJ/NPK.Operating loss totalled JPY 5,423 million (US$35.8 million) vs. an operating loss of JPY 9,526 million (US$67.8 million) in the prior year. This improvement in profitability reflects the combined effect of all movements explained above.Loss before income tax totalled JPY 4,662 million (US$30.8 million) vs. a loss before income tax of JPY 10,680 million (US$76.0 million) in the prior year. This improvement in profitability reflects the combined effect of all movements explained above.Net loss for the year ended 31 December 2024 totalled JPY 4,838 million (US$31.9 million) vs. a net loss of JPY 7,193 million (US$51.2 million) in the prior year. This improvement in profitability reflects the combined effect of all movements explained above.Core operating profit** totalled JPY 3,606 million (US$23.8 million) vs. a core operating loss of JPY 3,076 million (US$21.9 million) in the prior corresponding period. Cash and cash equivalents as at 31 December 2024 amounted to JPY 32,268 million (US$205.8 million) having decreased by JPY 16,797 million (decreased by US$142.1 million) from the beginning of the year. *Convenience conversion to US$ at the following rates: FY 2024: 1US$ =151.43 JPY; FY 2023: 1US$ =140.53 JPY; 31 Dec 2024: 1US$ = 156.83 JPY; 31 Dec 2023: 1US$ = 141.03 JPY ** Core operating profit / loss is an alternative performance measure which adjusts for material non-cash costs and one-off costs in order to provide insights into the recurring cash generation capability of the core business. –END– About Nxera PharmaNxera Pharma is a technology powered biopharma company, in pursuit of new specialty medicines to improve the lives of patients with unmet needs in Japan and globally. In addition to several products being commercialized in Japan, we are advancing an extensive pipeline of over 30 active programs from discovery through to late clinical stage internally and in partnership with leading pharma and biotech companies. This pipeline is focused on addressing major unmet needs in some of the fastest-growing areas of medicine across neurology, GI and immunology, metabolic disorders and rare diseases, and leverages the power of our unique and industry leading GPCR-targeted structure-based drug discovery NxWaveTM platform to provide a sustainable source of best- or first-in-class candidates. Nxera employs over 350 talented people at key locations in Tokyo and Osaka (Japan), London and Cambridge (UK), Basel (Switzerland) and Seoul (South Korea) and is listed on the Tokyo Stock Exchange (ticker: 4565). For more information, please visit www.nxera.life LinkedIn: @NxeraPharma | X: @NxeraPharma | YouTube: @NxeraPharma Enquiries: Nxera – Media and Investor RelationsKentaro Tahara, VP Investor Relations and Corporate StrategyShinichiro Nishishita, VP Investor Relations, Head of Regulatory DisclosuresMaya Bennison, Communications Manager+81 (0)3 5210 3399 | +44 (0)1223 949390 | IR@Nxera.life MEDiSTRAVA (for International Media)Mark Swallow, Frazer Hall, Erica Hollingsworth+44 (0)203 928 6900 | Nxera@medistrava.com Forward-looking statementsThis press release contains forward-looking statements, including statements about the discovery, development, and commercialization of products. Various risks may cause Nxera Pharma Group’s actual results to differ materially from those expressed or implied by the forward looking statements, including: adverse results in clinical development programs; failure to obtain patent protection for inventions; commercial limitations imposed by patents owned or controlled by third parties; dependence upon strategic alliance partners to develop and commercialize products and services; difficulties or delays in obtaining regulatory approvals to market products and services resulting from development efforts; the requirement for substantial funding to conduct research and development and to expand commercialization activities; and product initiatives by competitors. As a result of these factors, prospective investors are cautioned not to rely on any forward-looking statements. We disclaim any intention or obligation to update or revise any forward-looking statements, whether as a result of new information, future events or otherwise. Attachment FY24YE Tanshin_NxeraPharma